Physical therapy and deep brain stimulation in Parkinson’s Disease: Protocol for a pilot randomized controlled trial

Abstract Background Subthalamic nucleus deep brain stimulation (STN-DBS) reduces tremor, muscle stiffness, and bradykinesia in people with Parkinson’s Disease (PD). Walking speed, known to be reduced in PD, typically improves after surgery; however, other important aspects of gait may not improve. Furthermore, balance may worsen and falls may increase after STN-DBS. Thus, interventions to improve balance and gait could reduce morbidity and improve quality of life following STN-DBS. Physical therapy (PT) effectively improves balance and gait in people with PD, but studies on the effects of PT have not been extended to those treated with STN-DBS. As such, the efficacy, safety, and feasibility of PT in this population remain to be determined. The purpose of this pilot study is to address these unmet needs. We hypothesize that PT designed to target balance and gait impairment will be effective, safe, and feasible in this population. Methods/design Participants with PD treated with STN-DBS will be randomly assigned to either a PT or control group. Participants assigned to PT will complete an 8-week, twice-weekly PT program consisting of exercises designed to improve balance and gait. Control group participants will receive the current standard of care following STN-DBS, which does not include prescription of PT. The primary aim is to assess preliminary efficacy of PT on balance (Balance Evaluation Systems Test). A secondary aim is to assess efficacy of PT on gait (GAITRite instrumented walkway). Participants will be assessed OFF medication/OFF stimulation and ON medication/ON stimulation at baseline and at 8 and 12 weeks after baseline. Adverse events will be measured over the duration of the study, and adherence to PT will be measured to determine feasibility. Discussion To our knowledge, this will be the first study to explore the preliminary efficacy, safety, and feasibility of PT for individuals with PD with STN-DBS. If the study suggests potential efficacy, then this would justify larger trials to test effectiveness and safety of PT for those with PD with STN-DBS. Trial registration NCT03181282 (clinicaltrials.gov). Registered on 7 June 2017

International consensus on (ICON) anaphylaxis

ICON: Anaphylaxis provides a unique perspective on the principal evidence-based anaphylaxis guidelines developed and published independently from 2010 through 2014 by four allergy/immunology organizations. These guidelines concur with regard to the clinical features that indicate a likely diagnosis of anaphylaxis -- a life-threatening generalized or systemic allergic or hypersensitivity reaction. They also concur about prompt initial treatment with intramuscular injection of epinephrine (adrenaline) in the mid-outer thigh, positioning the patient supine (semi-reclining if dyspneic or vomiting), calling for help, and when indicated, providing supplemental oxygen, intravenous fluid resuscitation and cardiopulmonary resuscitation, along with concomitant monitoring of vital signs and oxygenation. Additionally, they concur that H1-antihistamines, H2-antihistamines, and glucocorticoids are not initial medications of choice. For self-management of patients at risk of anaphylaxis in community settings, they recommend carrying epinephrine auto-injectors and personalized emergency action plans, as well as follow-up with a physician (ideally an allergy/immunology specialist) to help prevent anaphylaxis recurrences. ICON: Anaphylaxis describes unmet needs in anaphylaxis, noting that although epinephrine in 1 mg/mL ampules is available worldwide, other essentials, including supplemental oxygen, intravenous fluid resuscitation, and epinephrine auto-injectors are not universally available. ICON: Anaphylaxis proposes a comprehensive international research agenda that calls for additional prospective studies of anaphylaxis epidemiology, patient risk factors and co-factors, triggers, clinical criteria for diagnosis, randomized controlled trials of therapeutic interventions, and measures to prevent anaphylaxis recurrences. It also calls for facilitation of global collaborations in anaphylaxis research. In addition to confirming the alignment of major anaphylaxis guidelines, ICON: Anaphylaxis adds value by including summary tables and citing 130 key references. It is published as an information resource about anaphylaxis for worldwide use by healthcare professionals, academics, policy-makers, patients, caregivers, and the public

An exploratory study of female South African university students’ knowledge and perceptions of subdermal contraceptive implants

South Africa‟s recent efforts to improve contraceptive uptake include the public launch of the subdermal contraceptive implant (branded Implanon NXT®). The launch of this modern contraceptive was welcomed as an initiative that holds promise in addressing elevated unintended pregnancy rates in the country. However, a paucity of research regarding the uptake of this contraceptive exists. This study sought to narrow this research gap by exploring the knowledge and perceptions that young female South African university students have of contraceptive implants, as well as investigate how these views may shape the willingness for these females to incorporate contraceptive implants into their birth control regimen. Semi-structured interviews were conducted with young female students enrolled at Nelson Mandela University and data from these interviews was analysed using thematic analysis. Findings were examined through a lens of social constructionism and critical psychology. Analysis revealed the following key findings: the function, suitability, and negative perceptions, of a particular contraceptive are notable considerations taken into account by young female university students when investigating contraceptives; psychosocial challenges are prominent in the arena of contraception; contraceptive implants possess the potential to reduce stigmatisation and empower women; however, participants asserted that there are significant psychosocial and structural barriers to the uptake of this contraceptive. These findings highlighted that contraceptive knowledge and perceptions are influenced by an interplay of psychosocial and structural factors. These factors were ultimately noted to influence young female South African university students‟ willingness to incorporate contraceptive implants into their birth control regimen

Report on eighth WHO meeting on development of influenza vaccines that induce broadly protective and long-lasting immune responses: Chicago, USA, 23-24 August 2016

In August 2016, the World Health Organization (WHO) convened the "Eighth meeting on development of influenza vaccines that induce broadly protective and long-lasting immune responses" to discuss the regulatory requirements and pathway

Improving human interaction research through ecological grounding

In psychology, we tend to follow the general logic of falsificationism: we separate the ‘context of discovery’ (how we come up with theories) from the ‘context of justification’ (how we test them). However, when studying human interaction, separating these contexts can lead to theories with low ecological validity that do not generalize well to life outside the lab. We propose borrowing research procedures from well-established inductive methodologies in interaction research during the process of discovering new regularities and analyzing natural data without being led by theory. We introduce research procedures including the use of naturalistic study settings, analytic transcription, collections of cases, and data analysis sessions, and illustrate these with examples from a successful cross-disciplinary study. We argue that if these procedures are used systematically and transparently throughout a research cycle, they will lead to more robust and ecologically valid theories about interaction within psychology and, with some adaptation, can enhance the reproducibility of research across many other areas of psychological science

Cost-Effectiveness of Introducing the SILCS Diaphragm in South Africa.

BACKGROUND: Though South Africa has high contraceptive use, unintended pregnancies are still widespread. The SILCS diaphragm could reduce the number of women with unmet need by introducing a discreet, woman-initiated, non-hormonal barrier method to the contraceptive method mix. METHODS: A decision model was built to estimate the impact and cost-effectiveness of the introduction of the SILCS diaphragm in Gauteng among women with unmet need for contraception in terms of unintended and mistimed pregnancies averted, assuming that the available contraceptives on the market were not a satisfying option for those women. Full costs were estimated both from a provider's and user's perspective, which also accounts for women's travel and opportunity cost of time, assuming a 5% uptake among women with unmet contraceptive need. The incremental cost-effectiveness ratio is computed at five and 10 years after introduction to allow for a distribution of fixed costs over time. A probabilistic sensitivity analysis was conducted to incorporate decision uncertainty. RESULTS: The introduction of the SILCS diaphragm in Gauteng could prevent an estimated 8,365 unintended pregnancies and 2,117 abortions over five years, at an annual estimated cost of US$55 per woman. This comes to a cost per pregnancy averted of US$153 and US$171 from a user's and provider's perspectives, respectively, with slightly lower unit costs at 10 years. Major cost drivers will be the price of the SILCS diaphragm and the contraceptive gel, given their large contribution to total costs (around 60%). CONCLUSIONS: The introduction of the SILCS diaphragm in the public sector is likely to provide protection for some women for whom current contraceptive technologies are not an option. However to realize its potential, targeting will be needed to reach women with unmet need and those with likely high adherence. Further analyses are needed among potential users to optimize the introduction strategy